Peace Out Acne

Description

The product is a topical gel formulation containing the active ingredient Adapalene, which is chemically defined as (6-(1S)-1-(4-ethoxyphenyl)-2-(2,2,2-trifluoroethoxy)ethylnaphthalene-1-carboxylic acid. The molecular formula of Adapalene is C18H20F3O3, with a molecular weight of 345.35. The gel appears as a clear, colorless to pale yellow substance. Inactive ingredients include Carbomer 940, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Disodium EDTA, Glycerin, Propylene Glycol, Purified Water, Sodium Hydroxide (for pH adjustment), and Tromethamine.

Uses and Indications

This drug is indicated for the treatment of acne. It is intended for use in patients diagnosed with acne vulgaris, providing therapeutic benefits to manage and reduce the severity of this condition.

Dosage and Administration

Healthcare professionals are advised to ensure that the affected area is thoroughly cleansed prior to the application of the medication. The medication should be applied using the provided sticker directly onto the affected area.

For new users, it is recommended to conduct a sensitivity test. This involves applying the product sparingly to one or two small affected areas over the course of the first three days. If no discomfort or adverse reactions are observed, the user may proceed with the standard application instructions.

In cases where bothersome dryness or peeling occurs, it is advisable to reduce the frequency of application to once daily or even every other day, depending on the severity of the symptoms.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from open fire or flame during use.

Caution is advised when using this product in conjunction with other topical acne medications, as the likelihood of skin irritation and dryness may increase. In the event of irritation, it is recommended that only one medication be utilized to mitigate adverse effects.

This product should not be used by individuals with known allergies to the dressing or any of its components.

In case of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Side Effects

Patients using this medication may experience skin irritation and dryness, particularly if another topical acne medication is used concurrently. In such cases, it is advised that only one medication be utilized to minimize the risk of irritation.

Additionally, patients should not use this product if they have a known allergy to the dressing or any of its components, as this could lead to serious allergic reactions. It is important for patients to be aware of these potential adverse reactions and to consult with their healthcare provider if they experience any concerning symptoms.

Drug Interactions

The concurrent use of topical acne medications may increase the risk of skin irritation and dryness. It is advisable to avoid the simultaneous application of multiple topical acne treatments. In cases where irritation occurs, it is recommended to discontinue one of the medications to mitigate adverse effects. Monitoring for signs of skin irritation is essential to ensure patient comfort and treatment adherence.

Packaging & NDC

Below are the non-prescription pack sizes of Peace Out Acne (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information regarding the use of Peace Out Acne (salicylic acid patch) in lactating mothers or lactation considerations. The prescribing information does not address the excretion of salicylic acid in breast milk or its effects on breastfed infants. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this product to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is vital to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Care should be taken to keep the product away from open fire or flame to prevent any potential hazards. Additionally, it is crucial to keep the product out of reach of children to ensure safety.

Additional Clinical Information

The medication is administered topically. Clinicians should advise patients to cleanse the affected area thoroughly before applying the medication. The application should involve placing the sticker directly on the affected area. If patients experience bothersome dryness or peeling, they are instructed to reduce the frequency of application to once daily or every other day.

For new users, a sensitivity test is recommended: patients should apply the product sparingly to one or two small affected areas during the first three days. If no discomfort is noted, they may proceed with the standard application instructions.

Drug Information (PDF)

This file contains official product information for Peace Out Acne, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)